Article Impact Level: HIGH Data Quality: STRONG Summary of JAMA Ophthalmology https://doi.org/10.1001/jamaophthalmol.2025.4253 Dr. Francis W. Price Jr, et al.
Points
- The study aimed to determine if donor diabetes affects 1-year DMEK graft success rates.
- A multicenter, randomized trial included 1097 individuals (1421 eyes) undergoing low to moderate risk DMEK.
- 1-year graft success was 96.3% for non-diabetic donors and 97.1% for diabetic donors, showing no significant difference (P=0.63).
- Failure rates, including primary donor failure, were comparable between diabetic and non-diabetic donor groups.
- The findings support expanding the donor pool to include corneas from diabetic donors without compromising DMEK success.
Summary
This multicenter, double-masked, randomized clinical trial investigated whether donor diabetes status affects the 1-year success rate of Descemet Membrane Endothelial Keratoplasty (DMEK). The primary objective was to determine if expanding the donor pool to include corneas from diabetic donors would compromise graft success. The study, conducted from February 2022 to July 2025 across 28 clinical sites with 46 surgeons and 13 US eye banks, included 1097 individuals (1421 study eyes; median age, 71 years [IQR 66-76]; 57.5% female) undergoing low to moderate risk DMEK, predominantly for Fuchs endothelial corneal dystrophy. Donor corneas were assigned using a minimization procedure, with an approximate 2:1 distribution for non-diabetic versus diabetic donors, respectively.
The main outcome measured was graft success at 1 year. The 1-year cumulative probability of graft success was 96.3% (95% CI, 95.0%-97.5%) for 912 study eyes (64.2%) receiving tissue from non-diabetic donors, and 97.1% (95% CI, 95.5%-98.4%) for 509 study eyes (35.8%) receiving tissue from diabetic donors. The observed difference between these groups was 0.7 percentage points (95% CI, −1.2 to 2.6; P = 0.63), indicating no statistically significant difference in success rates. Further analysis by diabetes severity also showed comparable results, with a 96.5% (95% CI, 93.6%-98.9%) success rate in the mild donor diabetes subgroup (n=173) and 97.3% (95% CI, 95.4%-98.8%) in the moderate to severe subgroup (n=336).
Failure rates, including primary donor failure, early surgical complication-related failure, and subsequent failure, were also comparable across donor groups. For non-diabetic donors, these rates were 2.5% (23 of 912), 0.7% (6 of 912), and 0.3% (3 of 912), respectively. For diabetic donors, the corresponding rates were 2.6% (13 of 509), 0.4% (2 of 509), and 0%. Crucially, no failures were attributed to graft rejection in either group. These findings strongly suggest that the presence of diabetes in the donor does not adversely affect the 1-year DMEK graft success rate, supporting the expansion of the donor pool.
Link to the article: https://jamanetwork.com/journals/jamaophthalmology/fullarticle/2840288
References
Price, F. W., Szczotka-Flynn, L. B., Price, M. O., Bauza, C. E., Reed, Z. W., Arafah, B. M., Greiner, M. A., Johnson, P. J., Keeler, D. B., Mian, S. I., Patel, S. V., Pramanik, S., Soper, M. C., Terry, M. A., Titus, M. S., Verdier, D. D., Kollman, C., Beck, R. W., Lass, J. H., … Wadleigh, G. (2025). Donor diabetes and 1-year descemet membrane endothelial keratoplasty success rate: A randomized clinical trial. JAMA Ophthalmology. https://doi.org/10.1001/jamaophthalmol.2025.4253
